What qualifications are needed for the export of epidemic materials such as face mask?

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2020-05-27

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According to US media reports on the 25th, the US Secretary of Health and Human Services Alex Aza admitted during the meeting of the Senate Appropriation Subcommittee that day, in response to the possible outbreak of the new coronary pneumonia virus, there is a huge gap in the supply of face mask and ventilators in the United States. Among them, the gap of masks is as high as 270 million.

Recently, the author also encountered some problems with some seller friends:

Seller 1: Can I export the face mask to the US now? We found DHL, but it was returned.
Seller 2: We want to send a box of face masks to friends in Australia in the past, worrying that they will not be detained. Is the customs allowed to export face masks now?

Prior to this, the Ministry of Commerce of China has clarified that the Chinese government has not set up any trade control measures for the export of face masks and their raw materials. Enterprises can carry out relevant trade in accordance with the principle of marketization, that is, the epidemic materials such as face masks can be exported normally .

So what information is needed to export face masks made in China? What qualifications are required for foreign imports? Is there any standard? How to check whether the face mask is qualified?

Chinese export requirements

A. Export face mask, you need to provide these materials and information ↓ (the specific data map is attached below)
1: Business license
2: Enterprise production license
3: Product inspection report
4: Medical device registration certificate
5: Product manual, label.
6: Product batch / number
7: Product quality and safety book
8: Pictures of product samples and pictures of outer packaging

B. What qualifications are required for enterprises exporting epidemic materials?
Non-medical device-managed epidemic materials such as ordinary face masks can be directly exported by enterprises with import and export rights without supervision conditions. For epidemic materials such as face masks involved, three product certifications are required: A. Business license (the business scope includes medical device related), B. Product record certificate or registration certificate, C. Manufacturer test report, and then import and export management Enterprises, and then export. In addition, if the company wants to give away or substitute for overseas affiliates, it needs to provide a description of the situation.

C. What qualifications are required for the export of ordinary face masks and medical face masks, and which certificates are required.
General and medical refer to uses. The management of the Food and Drug Administration is managed according to product quality and standards. Face masks of Class II and Class III medical devices require a registration certificate or registration certificate before they can be exported. For the three certificates involved, see the answer to question 2.

D. How can I get 200 face masks for personal delivery to the United States?
Personal mail is currently not prohibited from exporting. For general express delivery in the US, FEDEX, UPS, DHL, EMS, SF and other express delivery companies can be considered. However, some people report that DHL will require the sender to provide FDA certification in the United States, some DHL simply refused, and some partners have been rejected by FEDEX. Then you can try the post office mail first, or before the mail, first call the various courier companies. However, the news we have obtained is that the mask does not have the US FDA certificate, and the US customs will refuse to enter the country.

E. How to check whether the face mask is qualified?

Log in to the official website of the "National Drug Administration" (www.nmpa.gov.cn), and then click the "Medical Devices"-"Domestic Devices" section. According to the instructions on the page, enter the medical device registration certificate number or company name of the mask, you can know the production information of the company related to the product, and the approval number information, you can know whether it is qualified.

Foreign import requirements

EU

Necessary information (qualification)
Bill of lading, packing list, invoice
Mask requirements

In the EU, masks are PPE personal protective equipment, "health-threatening substances and mixtures". From 2019, the new EU regulations PPE Regulation (EU) 2016/425 will be enforced. All masks exported to the EU must obtain CE certification under the requirements of the new regulations.

CE certification is a compulsory product safety certification system implemented by the European Union, the purpose of which is to protect the safety of life and property of people in the European Union.

United States

Necessary information (qualification)
Bill of lading, packing list, invoice

If you want to sell face masks imported from the United States, you must obtain FDA certification before you can conduct sales activities in the US domestic market. For self-use and gift masks, it is best to ask the United States whether it needs FDA certification or to purchase a face mask that originally passed FDA certification for export.

Face mask requirements
According to HHS (United States Department of Health and Human Services) regulations, NIOSH (National Institute of Occupational Safety and Health) classified its certified anti-particulate masks into 9 categories. The specific certification is operated by the NPPTL laboratory under NIOSH.

In the United States, according to the minimum filtration efficiency of the filter material, the masks can be divided into three levels-N, R, P.

N-type masks can only filter non-oily particulate matter, such as: dust, acid mist, paint mist, microorganisms, etc. Most suspended particles in air pollution are also non-oily.

Type R face mask is only suitable for filtering oily particulates and non-oily particulates, but when used for oily particulates, the limited use time should not exceed 8 hours.

P-type face mask can filter both non-oily particulate matter and oily particulate matter. Oily particulate matter such as: oil fume, oil mist, etc.

According to the difference in filtration efficiency, there is also a difference of 90,95,100, which refers to the minimum filtration efficiency of 90%, 95%, 99.97% under the test conditions specified in the standard.

N95 is not a specific product name. As long as it conforms to the N95 standard and has passed the NIOSH review, it can be called "N95 type face mask."

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What qualifications are needed for the export of epidemic materials such as face mask?